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FDA 510(k) Application Details - K962765
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K962765
Device Name
Wire, Guide, Catheter
Applicant
CORDIS CORP.
14201 N.W. 60TH AVE.
MIAMI LAKES, FL 33014 US
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Contact
Lisa Wells
Other 510(k) Applications for this Contact
Regulation Number
870.1330
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Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/16/1996
Decision Date
02/21/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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